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General Information

EstroGel is a topical gel containing 0.06% estradiol in an
absorptive hydroalcoholic gel base, formulated to provide a
controlled release of the hormone. It is designed to treat symptoms
associated with menopause.

It is specifically indicated for the treatment of moderate to
severe vasomotor symptoms associated with
menopause, including hot flashes. It is also
indicated for the treatment of moderate to severe symptoms of
vulvar and vaginal atrophy associated with the
menopause, especially when the atrophy is concurrent to vasomotor
symptoms.

The recommended topical dose of EstroGel is 1.25 g once daily,
delivered via metered pump. Recommended application is to the
posterior surface of the arm, from the back of the wrist to the
shoulder.

Clinical Results

FDA approval of EstroGel for the treatment of monopausal
vasomotor symptoms was based on a double-blind,
placebo-controlled study enrolling 145 women between 29 and 67
years of age. Subjects received either 1.25g EstroGel (n=72) or
placebo (n=73) once daily for 12 weeks. Primary endpoint
efficacies, measured by reduction in the occurrence of
moderate-to-severe hot flashes and reduction in severity of hot
flashes, were assessed at 4, 8, and 12 weeks. Results showed that
EstroGel produced a statistically significant decrease in both the
number and severity of hot flashes at 4 and 12 weeks (reduction at
8 weeks was not significant). Specifically, at 4 weeks, subjects
receiving EstroGel experienced 0.85 fewer hot flashes per day, and
a reduction in severity score of 0.32; at 12 weeks, EstroGel
subjects experienced 1.71 fewer hot flashes and a severity score
reduction of 0.49.

FDA approval of EstroGel for the treatment of vulvar and
vaginal atrophy was based on results of vagina wall
cytology examinations performed on all subjects at 12 weeks. A
significant increase in superficial epithelial cells was observed
for the EstroGel group; no significant increase was seen among the
placebo group.

Side Effects

Adverse events associated with the use of EstroGel may include
(but are not limited to) the following:

Infection

Abdominal Pain

Diarrhea

Weight Gain

Pap Smear: Suspiscious

Metrorrhagia

Vaginitis

Pruritus

Mechanism of Action

EstroGel supplies systemic estradiol, the primary estrogenic
hormone secreted by the human ovaries, which is lost during and
following menopause. Estradiol binds to widely distributed nuclear
receptors in estrogen sensitive tissues. It also acts to inhibit
the pituitary release of leutenizing hormone and follicle
stimulating hormone via negative feedback loop (elevated levels of
these hormones are customarily observed in postmenopausal
women).